As a “Frequently Asked Questionâ€, the USP is often queried about the determination of microbial limits and specified microorganisms. The following, obtained from USP, provides a clarification for this commonly asked question. In determining the appropriate microbial limit, the USP Microbiology Expert Committee considers such matters as the … [Read more...]
USP FAQ – HOW ARE MICROBIAL LIMITS AND OBJECTIONABLE (SPECIFIED) MICROORGANISMS DETERMINED
COMMENT A question that is frequently asked during consulting, webinars and seminars is how does one choose appropriate microbial limits, especially with non-sterile raw materials, intermediates and final products. The USP Microbiological Expert Committee has considered this issue and provided Guidance. Please read their considerations below. In determining the appropriate … [Read more...]
